Mylan secured regulatory approval for remdesivir lyophilized powder for injection 100 mg/vial in India for restricted emergency use in COVID-19 patients

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On Jul. 6, 2020, Mylan announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic.

The drug was approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The drug will be launched under the brand name DESREMル in India, and will be available to patients in Jul. at a price of INR 4,800, which is more than 80% less than the price at which the branded version of this product will be available to governments in the developed world.

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Source: Mylan N.V.
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